MAUDE Adverse Event Report: BIOMET MICROFIXATION BIOMET MICROFIXATION FACIAL PLATING SYSTEM; 90 DEGREE CONTRA ANGLE SCREWDRIVER

Model Number N/A

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 04/12/2017

Event Type  malfunction  

Manufacturer Narrative

Review of device history records show the lot released with no recorded anomaly or deviation.Current information is insufficient to permit a valid conclusion about the cause of this event; a follow-up report will be sent upon completion of the device evaluation.Report three of three for the same event, reference reports 0001032347-2017-00368 and 0001032347-2017-00369.

Event Description

It was reported four contra angled drivers that failed to function during a demonstration lab.One driver was sticking, two would not click into place, and one would not go into reverse.There is no surgery or patient involvement.

Manufacturer Narrative

The product identity was confirmed in the evaluation.The drivers were visually evaluated and looked to be in good condition.The drivers were functionally evaluated by inserting a screw into white oak with contra angle blade.Three of the four drivers were able to successfully seat a screw but exhibited rough rotation which is indicative of a bent drive shaft from excessive force.The driver that was not able to seat a screw was found to be stripped.It was disassembled and there was damage to the gear teeth and a bent drive shaft.The most likely cause of the broken drivers was determined to be excessive force.Instruction for use states: "avoid undue stress or strain when handling or cleaning instruments." this is supplemental report three of three for the same event.Reports one and two are reported on mfr #0001032347-2017-00368 and 0001032347-2017-00369.

• Brand Name: BIOMET MICROFIXATION FACIAL PLATING SYSTEM
• Type of Device: 90 DEGREE CONTRA ANGLE SCREWDRIVER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6553598
• MDR Text Key: 74745650
• Report Number: 0001032347-2017-00370
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 24-1189
• Device Lot Number: 306440
• Other Device ID Number: (01)00841036123130(10)306440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1